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NCT02747108: FINDIT

ForgIng New Paths to Prevent DIabeTes (FINDIT)

Completed NA Results posted Last updated 25 July 2023
What this trial tests

NA trial testing Blood Test Group Intervention in Prediabetes in 315 participants. Completed in 30 March 2020.

Timeline
2 December 2015
Primary endpoint
1 December 2018
30 March 2020

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment315
Start date2 December 2015
Primary completion1 December 2018
Estimated completion30 March 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 75, any sex, with Prediabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Weight Change From Baseline to 12 Months Primary · 12 months

The primary outcome will be weight change 12 months after an HbA1c test and brief counseling or review of health promotion literature.

GroupValue95% CI
Blood Test Group (Normoglycemia)-.995535± 15.39902
Brochure Group (Usual Care)-2.1333341± 12.697408
Blood Test Group (Prediabetes).039778± 12.69741
Blood Test Group (Diabetes)-4.17± 9.906009
Change in Use of Medication for T2DM Prevention Secondary · 3 and 12 months

The investigators will use medical record data and survey data to evaluate changes in use of medication for T2DM prevention after an HbA1c test and brief counseling or review of health promotion literature.

3 months
GroupValue95% CI
Blood Test Group (Normoglycemia)0
Brochure Group (Usual Care)3
Blood Test Group (Prediabetes)0
Blood Test Group (Diabetes)3
Blood Test Group (Normoglycemia)134
Brochure Group (Usual Care)59
Blood Test Group (Prediabetes)106
Blood Test Group (Diabetes)8
12 months
GroupValue95% CI
Blood Test Group (Normoglycemia)2
Brochure Group (Usual Care)3
Blood Test Group (Prediabetes)2
Blood Test Group (Diabetes)2
Blood Test Group (Normoglycemia)132
Brochure Group (Usual Care)59
Blood Test Group (Prediabetes)104
Blood Test Group (Diabetes)9
Changes in Participation in a Weight Management Program Secondary · 3 months and 12 months

The investigators will use survey data to evaluate changes in participation in a weight management program after an HbA1c test and brief counseling or review of health promotion literature.

3 months
GroupValue95% CI
Blood Test Group (Normoglycemia)17
Brochure Group (Usual Care)8
Blood Test Group (Prediabetes)8
Blood Test Group (Diabetes)2
Blood Test Group (Normoglycemia)117
Brochure Group (Usual Care)54
Blood Test Group (Prediabetes)98
Blood Test Group (Diabetes)9
12 months
GroupValue95% CI
Blood Test Group (Normoglycemia)20
Brochure Group (Usual Care)10
Blood Test Group (Prediabetes)8
Blood Test Group (Diabetes)2
Blood Test Group (Normoglycemia)114
Brochure Group (Usual Care)52
Blood Test Group (Prediabetes)98
Blood Test Group (Diabetes)9
Changes in Perception for Risk for T2DM Secondary · Baseline, 2 weeks, 3 months, and 12 months

The investigators will use survey data to evaluate changes in perception of risk for T2DM after an HbA1c test and brief counseling or review of health promotion literature. The Adriaanse T2DM Risk Perception Scale, which was included in the survey, measured self-assessed risk perception from 0 denoting no choice of developing T2DM to 100 denoting absolute confidence in developing T2DM.

Baseline
GroupValue95% CI
Blood Test Group (Normoglycemia)20.775± 1.84
Brochure Group (Usual Care)21.724± 2.611
Blood Test Group (Prediabetes)27.596± 2.554
Blood Test Group (Diabetes)35.455± 6.112
2 weeks
GroupValue95% CI
Blood Test Group (Normoglycemia)16.356± 1.704
Brochure Group (Usual Care)23.684± 2.519
Blood Test Group (Prediabetes)36.327± 2.41
Blood Test Group (Diabetes)56± 6.452
3 months
GroupValue95% CI
Blood Test Group (Normoglycemia)19± 1.738
Brochure Group (Usual Care)26.667± 3.036
Blood Test Group (Prediabetes)35.851± 2.377
Blood Test Group (Diabetes)51.25± 6.031
12 months
GroupValue95% CI
Blood Test Group (Normoglycemia)18.947± 1.943
Brochure Group (Usual Care)23.585± 3.265
Blood Test Group (Prediabetes)32.5± 2.504
Blood Test Group (Diabetes)43.333± 7.183
Changes in Knowledge of Strategies to Prevent T2DM Secondary · 2 weeks, 3 months, and 12 months

The investigators will use survey data to evaluate changes in knowledge of strategies to prevent T2DM after an HbA1c test and brief counseling or review of health promotion literature. Respondents were given 3 open-ended questions to report things they could do to prevent T2DM. Each respective response to the 3 questions were coded and scored according to whether they indicated engagement in the following activities: weight loss, physical activity, use of metformin, or enrollment into a diabetes prevention program. Each question denoted with a positive response were coded with 1 whereas those

2 weeks
GroupValue95% CI
Blood Test Group (Normoglycemia)1.03± 0.70
Brochure Group (Usual Care)1.10± 0.65
Blood Test Group (Prediabetes)1.34± 0.77
Blood Test Group (Diabetes)1.09± 0.70
3 months
GroupValue95% CI
Blood Test Group (Normoglycemia)1.04± 0.64
Brochure Group (Usual Care)1.01± 0.67
Blood Test Group (Prediabetes)1.08± 0.66
Blood Test Group (Diabetes)1.09± 0.83
12 months
GroupValue95% CI
Blood Test Group (Normoglycemia)1.03± 0.72
Brochure Group (Usual Care)0.97± 0.68
Blood Test Group (Prediabetes)1.08± 0.69
Blood Test Group (Diabetes)1.18± 0.87
Changes in Motivation to Prevent T2DM Secondary · Baseline, 2 weeks, 3 months, and 12 months

The investigators will use survey data to evaluate changes in motivation to prevent T2DM after an HbA1c test and brief counseling or review of health promotion literature. The Treatment Self-Regulation Questionnaire (TSRQ) was included in the survey and respondents were asked about their level of motivation from 1 (Not at all motivated) to 10 (Highly motivated).

Baseline
GroupValue95% CI
Blood Test Group (Normoglycemia)6.618± .239
Brochure Group (Usual Care)7.237± .358
Blood Test Group (Prediabetes)6.676± .272
Blood Test Group (Diabetes)6.455± .627
2 weeks
GroupValue95% CI
Blood Test Group (Normoglycemia)6.558± .24
Brochure Group (Usual Care)7.246± .321
Blood Test Group (Prediabetes)7.67± .215
Blood Test Group (Diabetes)7.9± .432
3 months
GroupValue95% CI
Blood Test Group (Normoglycemia)6.471± .229
Brochure Group (Usual Care)7.018± .323
Blood Test Group (Prediabetes)7.442± .221
Blood Test Group (Diabetes)7± .537
12 months
GroupValue95% CI
Blood Test Group (Normoglycemia)6.793± .234
Brochure Group (Usual Care)6.981± .371
Blood Test Group (Prediabetes)7.207± .236
Blood Test Group (Diabetes)6.889± .897
Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM Secondary · Baseline, 3 months and 12 months

The investigators will use survey data to evaluate changes in self-efficacy to engage in behaviors to prevent T2DM after an HbA1c test and brief counseling or review of health promotion literature. The Perceived Competence Scale was used to measure respondent self-efficacy from 1 (lowest) to 7 (highest).

Baseline
GroupValue95% CI
Blood Test Group (Normoglycemia)4.869± .134
Brochure Group (Usual Care)5.082± .172
Blood Test Group (Prediabetes)4.747± .152
Blood Test Group (Diabetes)4.341± .445
3 months
GroupValue95% CI
Blood Test Group (Normoglycemia)4.926± .125
Brochure Group (Usual Care)5.005± .192
Blood Test Group (Prediabetes)4.826± .148
Blood Test Group (Diabetes)4.906± .432
12 months
GroupValue95% CI
Blood Test Group (Normoglycemia)5.07± .134
Brochure Group (Usual Care)5.31± .195
Blood Test Group (Prediabetes)4.832± .151
Blood Test Group (Diabetes)4.75± .57
Change in Physical Activity Secondary · Baseline, 3 months and 12 months

The investigators will use survey data to evaluate changes in physical activity after an HbA1c test and brief counseling or review of health promotion literature. The International Physical Activity Questionnaire - Short Form (IPAQ-SF) was used to measure physical activity change. Respondents were asked to report how many hours and minutes within the past week they completed of vigorous physical activity, moderate physical activity, and brisk walking. The total sum of minutes for these three questions were subsequently coded into a yes/no binary variable for whether respondents met a recommend

Baseline
GroupValue95% CI
Blood Test Group (Normoglycemia).542± .044
Brochure Group (Usual Care).5± .066
Blood Test Group (Prediabetes).495± .047
Blood Test Group (Diabetes).273± .138
3 months
GroupValue95% CI
Blood Test Group (Normoglycemia).45± .042
Brochure Group (Usual Care).517± .063
Blood Test Group (Prediabetes).438± .047
Blood Test Group (Diabetes).091± .087
12 months
GroupValue95% CI
Blood Test Group (Normoglycemia).489± .043
Brochure Group (Usual Care).5± .063
Blood Test Group (Prediabetes).457± .047
Blood Test Group (Diabetes).364± .145
Change in Mental Health Secondary · Baseline, 2 weeks, 3 months, and 12 months

The investigators will use survey data to evaluate changes in SF-12 mental health scores after an HbA1c test and brief counseling or review of health promotion literature. The SF-12 provides a calculation of (1) a physical score (PCS-12) generated from a subset of questions focused on physical health and (2) a mental health score (MCS-12) generated from a subset of questions focused on mental health. The data provided represent the mean score of the PCS-12 and MCS-12. Scores range from 0 to 100, where a zero score indicates the lowest level of physical/mental health measured by the scales and

Baseline
GroupValue95% CI
Blood Test Group (Normoglycemia)44.995± 9.63
Brochure Group (Usual Care)44.264± 1.43
Blood Test Group (Prediabetes)45.373± 1.086
Blood Test Group (Diabetes)37.926± 2.291
2 weeks
GroupValue95% CI
Blood Test Group (Normoglycemia)46.366± 1.018
Brochure Group (Usual Care)46.389± 1.496
Blood Test Group (Prediabetes)46.512± 1.071
Blood Test Group (Diabetes)44.806± 2.548
3 months
GroupValue95% CI
Blood Test Group (Normoglycemia)45.347± 1.037
Brochure Group (Usual Care)48.249± 1.531
Blood Test Group (Prediabetes)46.926± 1.095
Blood Test Group (Diabetes)48.703± 3.139
12 months
GroupValue95% CI
Blood Test Group (Normoglycemia)47.082± 1.082
Brochure Group (Usual Care)47.308± 1.37
Blood Test Group (Prediabetes)47.58± 1.066
Blood Test Group (Diabetes)40.085± 4.352

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events are reported for the full year of participation of each individual.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Blood Test Group
Serious: 0/253 (0%)
Deaths: 2/253
Brochure Group (Usual Care)
Serious: 0/62 (0%)
Deaths: 2/62
Other adverse events (4 terms — click to expand)

ReactionSystemBlood Test GroupBrochure Group (Usual Care)
Surgical and medical proceduresSurgical and medical procedures
Self-report of cold/flu/sinus infectionRespiratory, thoracic and mediastinal disorders
Diagnosis of cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious depressionPsychiatric disorders

Data from ClinicalTrials.gov NCT02747108 adverse events section.

Sponsor's own description

This study will evaluate the effects of screening for type 2 diabetes mellitus (T2DM) and brief counseling about screening test results on weight and key health behaviors among Veterans with risk factors for T2DM. Study participants will be randomly assigned to one of two study groups: (1) Blood Test Group or (2) Brochure Group. Participants in the Blood Test Group will complete a blood test called hemoglobin A1c (HbA1c) which measures average blood sugar levels. Participants will receive brief counseling about the results from their primary care provider or someone authorized to speak on their behalf. Participants randomly selected for the Brochure Group will review a handout from the VA National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations. All participants will be asked to complete a survey prior to study group assignment, immediately after a Primary Care appointment, 3 months after enrollment, and 12 months after enrollment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. ForgIng New paths in DIabetes PrevenTion (FINDIT): Study Protocol for a Randomized Controlled Trial.
    Kullgren JT, Youles B, Shetty S, Richardson C, et al · · 2017 · cited 1× · PMID 28388933 · DOI 10.1186/s13063-017-1887-6

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02747108.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing